ContraVir Pharmaceuticals (NASDAQ:CTRV) reported positive findings from its first study with human precision cut liver slice cultures.
In the experimental model, liver disease was simulated by application of several potent, profibrotic molecules, TGF-beta and PDGF. Co-administration of ContraVir’s clinical phase drug candidate, CRV431, was found to be 100% effective at preventing fibrosis induction beyond baseline levels.
CRV431 at clinically relevant concentrations also partially or completely blocked several genetic and protein biomarkers of inflammation and fibrosis.
In the experiment, CRV431 was more effective at preventing fibrosis than elafibranor and obeticholic acid (OCA), both Phase 3 drug candidates for the treatment of nonalcoholic steatohepatitis (NASH), which were tested simultaneously with ContraVir’s CRV431.
The beneficial effects of CRV431 on biomarkers of inflammation and fibrosis were similar to those of elafibranor and greater than those of OCA. CRV431 also exerted its therapeutic activities at lower concentrations than the other two late-stage drugs, suggesting that CRV431 is a highly potent pharmaceutical agent. At the same time, CRV431 did not demonstrate any negative effects on liver biomarkers, further supporting the safety profile of CRV431.
Dr. Robert Foster, CEO of ContraVir, said results from the study are highly meaningful because they come from fully intact samples of human livers.
“The closer that experimental models are to replicating what happens in the human body, the greater the likelihood that the therapeutic effects observed in the models will translate to human diseases,” he added.
Dr. Foster said these precision cut liver slices add to the growing list of experiments where CRV431 has demonstrated effectiveness and “gives us great confidence in developing CRV431 for NASH and other liver diseases.”
ContraVir is developing CRV431 for NASH, fibrosis and other liver diseases, such as viral hepatitis and hepatocellular carcinoma. A Phase 1, single ascending dose study previously showed CRV431 to be safe and well tolerated in humans. Currently, CRV431 is being administered in a 28-day multiple ascending dose study.